Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
CARBOPLATIN
OMEGA LABORATORIES LIMITED
L01XA02
CARBOPLATIN
10MG
SOLUTION
CARBOPLATIN 10MG
INTRAVENOUS
5/15/45/60ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0117892002; AHFS:
APPROVED
2011-03-30
PRODUCT MONOGRAPH Pr CARBOPLATIN INJECTION OMEGA STANDARD (CARBOPLATIN) 10 mg/mL Antineoplastic Omega Laboratories, Ltd. Preparation date: 11 177, Hamon March 24, 2011 Montréal, Canada H3M 3E4 Control No. 135287 2 Pr CARBOPLATIN INJECTION 10 MG/ML OMEGA STANDARD THERAPEUTIC CLASSIFICATION Antineoplastic CAUTION: CARBOPLATIN IS A POTENT DRUG AND SHOULD BE USED ONLY BY PHYSICIANS EXPERIENCED WITH CANCER CHEMOTHERAPEUTIC DRUGS (SEE WARNINGS AND PRECAUTIONS). BLOOD COUNTS AS WELL AS RENAL AND HEPATIC FUNCTION TESTS MUST BE DONE REGULARLY. DISCONTINUE THE DRUG IF ABNORMAL DEPRESSION OF BONE MARROW OR ABNORMAL RENAL OR HEPATIC FUNCTION IS SEEN. ACTION Carboplatin is a synthetic analogue of cisplatin. Like cisplatin, carboplatin interferes with DNA intrastrand and interstrand crosslinks in cells exposed to the drug. DNA reactivity has been correlated with cytotoxicity. Following administration of carboplatin in man, linear relationships exist between dose and plasma concentrations of total and free ultrafilterable platinum. The area under the plasma concentration versus time curve for total platinum also shows a linear relationship with the dose. Repeated dosing during four consecutive days did not produce an accumulation of platinum in plasma. 3 Following administration of carboplatin, reported values for the terminal elimination half-lives of free ultrafilterable platinum and carboplatin in man were approximately 6 hours and 1.5 hours, respectively. During the initial phase, most of the free ultrafilterable platinum is present as carboplatin. The terminal half-life for total plasma platinum is 24 hours. Approximately 87% of the plasma platinum is protein bound within 24 hours following administration. Carboplatin is excreted primarily in the urine with recovery of approximately 70% of the administered platinum within 24 hours. Most of the drug is excreted in the first 6 hours. Excretion of carboplatin is by glomerular filtration. Patients with poor renal function have a higher area under curve (AUC) for total platinu Baca dokumen lengkap